1. Field of the Invention
The present invention relates to emergency medical procedures. More particularly, the present invention relates to a device and method for the execution of an emergency tracheotomy.
2. Description of the Related Art
Tracheotomy is an operation for the purpose of relieving an obstruction of the respiratory passage. The device is used to restore the patient's breathing in critical situations when an emergency trauma center is not immediately available. In general, it is necessary to perform a dissection for the insertion of a breathing tube into the tracheal lumen. This procedure requires surgical skills and conventional apparatus are limited to experienced operators.
U.S. Pat. Nos. 3,688,773 and 3,817,250 describe an expandable needle, enlarged in a rear section and tapering to a sharp point for puncturing the skin and tissue of a patient. The sharp end of the needle is used to make the puncture and the entire needle is inserted into the trachea. An air tube is then inserted into the needle, expanding the same, and into the tracheal area to allow the patient to breathe.
Although these prior art devices represent an improvement over the devices previously known, there is a danger that unprotected sharp ends of the needle could be inserted too far into the trachea puncturing the soft posterior wall causing injury and severe complications. Also, the orifice made by the needle does not achieve a circular shape, but an ellipsoidal shape; therefore, the pressure made by the device through a forced dilatation often has the consequence of breaking the inter-cartilaginous membrane.
U.S. Pat. Nos. 4,978,334 describes a device that uses a dilator with a hollow needle. This procedure has the shortcomings that at the moment of the initial penetration through the skin or membrane or when withdrawing the syringe plunger, in order to verify if the tip of the needle is in the tracheal lumen, the use of a hollow needle can result in an obstruction made by fragments of tissues which occur within the needle. The obstruction causes the operator not to be able to evaluate with accuracy the location of the needle since there will not be a positive response. The use of a syringe as an auxiliary element also has the shortcoming that surgical skills are still required and the procedure's time is longer.
Another problem is the complete safe further insertion of the device once it is located within the tracheal lumen. U.S. Pat. No. 5,217,005 ('005) describes a sharp conical tip of a dilator. An annular groove is positioned at the base of the conical tip of the dilator for providing a safety element to avoid the puncturing of the posterior wall of the trachea. A guide wire is used to assist in the guiding of the dilator and the tube into the trachea. However, in spite of the fact that the annular groove becomes flexible after the needle tip is withdrawn, the tip of the dilator is still sharp and it can injure the posterior wall of the trachea in its advancing movement inside the trachea. Also, since the guide wire cannot secure an entirely safe advancement of the dilator's tip, the conic tip is rigid and the guide wire is flexible, a space can appear between the rigid wall of the dilator's conic tip and the curb made by the guide wire at its exit from the dilator. Accordingly, the sharp tip of the dilator's conic portion can scratch the posterior tracheal wall. It is described in the '005 patent that for children and patients with smaller body sizes the height of the conical portion of the dilator can be varied in order to prevent the dilator from injuring the posterior wall of the trachea. However, there is no disclosure in the patent adapting the device for patients with different skin and subcutaneous tissue thickness.
It is desirable to provide a percutaneous device to eliminate the risk of injury which can be used for all patients. Such a device is proposed by the present invention.